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GOOD DOCUMENTATION PRACTICES IN CLINICAL LABORATORY KEMRI-Wellcome Trust Research Programme

What is Good Documentation Practice? Document is information (meaningful data) and its supporting medium, in form of paper, CD, Computer file, microfilm, x-Ray film etc Documents provides information or evidence or may serve as an official record. Record is a document stating results achieved or provide evidence of activities performed. Guidelines is a document that provides recommended practices and instructions. Policy is a plan or adopted course or principle of action intended to influence and determine the decisions or actions of an organization. DEFINITION OF LABORATORY GOOD DOCUMENTATION PRACTICE Document is information (meaningful data) and its supporting medium, in form of paper, CD, Computer file, microfilm, x-Ray film etc Documents provides information or evidence or may serve as an official record. Record is a document stating results achieved or provide evidence of activities performed. Guidelines is a document that provides recommended practices and instructions. Policy is a plan or adopted course or principle of action intended to influence and determine the decisions or actions of an organization.

Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review and statistical analysis. Control of Process - Ensures all staff knows what to do and when to do it. To improve performance Regulatory requirements. Purpose of Laboratory Documentation To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc Ensures documented evidence, traceability, provide records and audit trails for investigation Ensures availability of data for validation, review and statistical analysis. Control of Process - Ensures all staff knows what to do and when to do it. To improve performance Regulatory requirements.

Types of Documentation and Records in Laboratory Standard Operating Procedures Laboratory Analytical Plans Laboratory Reference Standards Laboratory Note Books Temperature charts Corrective Action Preventive Action (CAPA) Lab staff training records Levey-Jennings chart Types of Documentation and Records in Laboratory Standard Operating Procedures Laboratory Analytical Plans Laboratory Reference Standards Laboratory Note Books Temperature charts Corrective Action Preventive Action (CAPA) Lab staff training records Levey-Jennings chart

What constitutes Good Documentation Legible: everyone should be able to read what is written regardless of who, where or what has been written. Concise: the document must provide clear information that is understood by all customers Traceable: who recorded it, where and why Contemporaneous: the information should be documented at the correct time frame along with flow of events Enduring: Long lasting and durable Accessible: Easily available for review. What constitutes Good Documentation Legible: everyone should be able to read what is written regardless of who, where or what has been written. Concise: the document must provide clear information that is understood by all customers Traceable: who recorded it, where and why Contemporaneous: the information should be documented at the correct time frame along with flow of events Enduring: Long lasting and durable Accessible: Easily available for review.

Documentation Process in the Laboratory Document creation and approval Document use and data collection Document maintenance and verification Record Review Record Modification and Correction Record Archiving Record Destruction Documentation Process in the Laboratory Document creation and approval: the process owner or the person authorized should write the document on a standard format. The creation of document should be the responsibility of everyone in the Laboratory. An approved document should be signed and dated by appropriate authorized personnel. The document are signed in permamnent ink. The local standardized date format is used to date the document. Document use and data collection Document maintenance and verification: the document should be reviewed regularly and kept current. The documents and records should be retained and made available for appropriate duration under appropriate conditions. Electronic document management systems should be validated and electronic records backed-up. Record Review Record Modification and Correction: Handwritten modifications are signed and dated. Where appropriate, the reason for alteration should be indicated. Electronic versions can be modified by authorized personnel and controlled by passwords or other means. A history must be maintained of changes and deletions to electronic versions. The corrections can be made on record by drawing a single line through the information that needs to be corrected. All corrections or alterations shall be signed and dated. The original data should remained legible. Only personnel who have been approved to write or make changes to a document can correct or add to documents. Non-typographical error corrections or additions indicating change in data or acceptance status require a comment and should pass through full document change control. Typographyical error change or additions do not require approval. Record Archiving Record Destruction

Common Documentation Errors Missing signature and dates at the time of activity performed. The write-over Non-uniform date and signature entry Writing a note that activity was performed on one day and signed for on other day. Blank spaces Illegible writing Too many corrections Common Documentation Errors Missing signature and dates at the time of activity performed. The write-over Non-uniform date and signature entry Writing a note that activity was performed on one day and signed for on other day. Blank spaces Illegible writing Too many corrections

Principles of Good Documentation Practice A document bearing original signatures should never be destroyed. Never falsify information Never you a White-out and cover-over-tapes Never obliterate information or record Never over-write a record. Never use pencil – all information should be completed in permanent Black or Blue ink No spaces, lines or fields are to be left blank Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive Principles of Good Documentation Practice A document bearing original signatures should never be destroyed. Never falsify information Never you a White-out and cover-over-tapes Never obliterate information or record Never over-write a record. Never use pencil – all information should be completed in permanent Black or Blue ink No spaces, lines or fields are to be left blank Never use symbols e.g ditto marks or arrows to indicate repetitive and consecutive

Benefits of Good Documentation Practice Build confidence in the Laboratory Quality System Reduce efforts to compliance with regulatory bodies Allows for achievements of required results. Correct, complete, current and consistent information effectively meets customers and stakeholders’ requirements. Enables the Laboratory activities to be arranged into functional patterns for specific action. Create structures so that staff can systematically coordinate to conduct business. Training of Laboratory staff. Solve complicated problems Reduce or eliminate assumptions and second-guessing. Benefits of Good Documentation Practice Build confidence in the Laboratory Quality System Reduce efforts to compliance with regulatory bodies Allows for achievements of required results. Correct, complete, current and consistent information effectively meets customers and stakeholders’ requirements. Enables the Laboratory activities to be arranged into functional patterns for specific action. Create structures so that staff can systematically coordinate to conduct business. Training of Laboratory staff. Solve complicated problems Reduce or eliminate assumptions and second-guessing. Eliminate the need to re-ask the same questions Specify clear instructions for staff

Benefits of Good Documentation Practice Eliminate the need to re-ask the same questions Specify clear instructions for staff